HighLife (Paris) recently announced it raised €80 million (more than $90 million U.S.) for a U.S. pivotal study and expanded European commercialization of its TMVR system. The successfully completed fundraise, announced Sept. 22, was co-led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners. Other new investors … [Read more...] about HighLife raises more than $90M to advance its TMVR system
nitinol
Anaconda Biomed brings in $56 million
Anaconda Biomed recently announced a $56 million funding round to advance what it describes as next-generation, novel thrombectomy catheters. The Barcelona-based company said the funds will support completion of the ongoing Athena pivotal IDE study, a prospective, randomized, 327-subject trial intended to evaluate the safety and performance of … [Read more...] about Anaconda Biomed brings in $56 million
Corcym achieves first-in-human implant of TriMemo for tricuspid valve repair
Corcym today announced that Cleveland Clinic doctors performed the first-in-human implantation of TriMemo, a semi-rigid ring designed to repair the tricuspid valve. The ring comprises three layers: a carbon film coating over the oval silicone sheath, which together guard the laser-cut nitinol cell structure. Nitinol, a superelastic … [Read more...] about Corcym achieves first-in-human implant of TriMemo for tricuspid valve repair
Galaxy Therapeutics’ SEAL embolization system gets CE mark
By Julia Rock-Torcivia Galaxy Therapeutics, a privately held medical device company focused on the treatment of intracranial aneurysms, today announced that it has received CE mark for its SEAL Embolization System. The CE mark follows successful assessment by Notified Body DQS Medizinprodukte GmbH. SEAL (which stands for Saccular … [Read more...] about Galaxy Therapeutics’ SEAL embolization system gets CE mark
Artivion earns FDA nod for aortic arch prosthesis device
Artivion (NYSE:AORT) announced today that it received FDA premarket approval (PMA) for its AMDS Hybrid Prosthesis device. The approval covers acute Debakey Type 1 aortic dissections with either clinical or radiographic malperfusion. Atlanta-based Artivion estimates that this population comprises approximately 60% of all Debakey Type 1 aortic … [Read more...] about Artivion earns FDA nod for aortic arch prosthesis device
CereVasc completes enrollment in eShunt trial
CereVasc announced today that it completed patient enrollment in the STRIDE pivotal trial evaluating its investigational eShunt system. Boston-based CereVasc said it completed enrollment at 32 clinical sites. Now, STRIDE continues to progress through remaining treatment and follow-up activities for consented patients. The company said it is on … [Read more...] about CereVasc completes enrollment in eShunt trial
Gore wins CE mark for Fortegra venous stent
W.L. Gore & Associates announced today that it received CE mark approval for its Viabahn Fortegra venous stent system. European approval comes about six months after the stent picked up FDA approval. The company labeled Viabahn Fortegra the first device for the treatment of deep venous disease in the inferior vena cava (IVC), iliac and … [Read more...] about Gore wins CE mark for Fortegra venous stent
Endologix acquires Pounce thrombectomy system from Surmodics
Endologix announced today that it acquired the Pounce thrombectomy system from Surmodics, closing the deal on May 18. Pounce, an FDA-cleared and commercially available fully mechanical thrombectomy platform, offers the non-surgical removal of thrombi and emboli from peripheral arteries. It comes in multiple configurations to support use across a … [Read more...] about Endologix acquires Pounce thrombectomy system from Surmodics
Prodeon gets FDA clearance for BPH-treating nitinol implant
Prodeon Medical announced today that it received FDA 510(k) clearance for its Urocross expander system. Sunnyvale, California-based Prodeon designed Urocross as a novel, non-permanent implant technology for treating lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). It marks the latest device of this kind … [Read more...] about Prodeon gets FDA clearance for BPH-treating nitinol implant
BD picks up CE mark for Revello vascular covered stent
BD (NYSE: BDX) announced today that it received CE mark approval for its Revello vascular covered stent system. Franklin Lakes, New Jersey–based BD designed Revello to treat atherosclerotic lesions in the common and external iliac arteries. The next-generation endovascular solution combines the flexibility of a nitinol self-expanding stent with … [Read more...] about BD picks up CE mark for Revello vascular covered stent
